Quality Assurance Engineer

Quality Assurance Engineer I The Quality Engineer designs, implements, and maintains quality assurance programs for processing materials into products and compliance with safety, and regulatory standards. This role designs methods and procedures for inspecting, testing, and evaluating the precision of production processes, equipment and finished products PRIMARY DUTIES AND RESPONSIBILITIES Designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products working as a conduit between Engineering/Technical teams to ensure quality conformance regarding product purchase specification, product sales specification, and product manufacturing specifications. Assess risk of production failures, process deviations, and customer complaints through root cause and trends investigation. Performs final sign off on product release Plans, implements, and manages compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. Conducts root cause analysis upon product failure and/or system breakdown. Acts as a first point of call after Quality control for investigations and decision on product uniformity. Audits supplier compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). May recommend a change in supplier if supplier doesn't meet company standards Leads, guides, and supports continuous improvement efforts including Kaizen, 6S, and other types of lean initiatives. Analyzes statistical data to support investigative and continuous improvement efforts Performs additional duties as assigned. MINIMUM REQUIREMENTS Bachelor's Degree in Quality, Mechanical, Industrial Engineering, or related Engineering field Two (2) years' experience in Quality Engineering, preferably in an ISO 9001 certified environment, and / or regulated environment (preferably life-science), and / or automated assembly organizations Experience working with Quality Management, Electronic Document Management, Product Data Management (PDM), Product Lifecycle Management (PLM) Excellent analytical, organizational and negotiation skills Must have excellent verbal and written communication skills, accuracy and attention to detail. Previous experience of facilitating training sessions. Must be familiar with engineering and manufacturing documentation, such as Bills of Material (BOMs). Must be proficient with Microsoft Office, Visio, and other business applications Must be proficient in the use of quality and statistical analysis software Good Knowledge and experience of SAP or similar ERP desired Must be able to operate in a fast-paced organization and handle multiple projects simultaneously within set timeframes. PREFERRED QUALIFICATIONS Three (3) year's related experience Certification in Quality Engineering, Quality Management, 6-sigma, lean, or related areas is highly desirable Previous experience in a Mechanical Engineering role Knowledge of the Cold Chain industry including knowledge of phase change materials, vacuum insulated panels, plastics, and packaging materials is also preferred Project management skills are highly desirable. SEE THE PELICAN WEBSITE FOR COMPLETE JOB DESCRIPTION